Drap asks pharma representatives to use online system instead of visiting its offices

ISLAMABAD: Introducing an online ‘centralised case management system’ to boost operational efficiency and ease of the business process for the pharmaceutical industry, the Drug Regulatory Authority of Pakistan (Drap) on Wednesday advised pharma industry representatives to use the online system instead of flocking its office during visiting hours.

“Drap has introduced an online centralised case management system designed to monitor the processing of applications and enable applicants to track their regulatory submissions and furnish additional details as required. This marks a significant step towards enhancing transparency and efficiency,” stated a notification issued by Drap’s Director of Pharmacy Services, Dr Obaidullah.

Drap officials have been under tremendous pressure from pharmaceutical industry representatives after the authority banned their entry into its new office complex located at the National Institute of Health (NIH) in Islamabad to ‘ensure transparency’. This led to the provision of a two-hour window for interactions with officers under electronic surveillance.

Instead of yielding to the demands of the pharmaceutical industry for uninterrupted access to all its officers, the Drap announced that all licensed/applicants of therapeutic goods manufacturers, importers, exporters, clinical trial sites, and CROs could access the centralised case management system on the eAPP module (www.eapp.drnaov.ok) of Drap through their existing secured account credentials, effective from May 29, 2024.

“This module ensures that submissions are forwarded to the director of the concerned divisions with visibility for applicants to track their cases and receive timely responses, monitored by Drap’s higher management. We are hopeful that implementing this new system will significantly improve the visibility of application processing and streamline regulatory operations,” the notification issued by the director of Pharmacy Services further stated.

The notification also recommended that instead of visiting the Drap office between 11:00 am and 1:00 pm, the applicants should use the eAPP to follow up on regulatory submissions.

Speaking to The News, Drap’s Chief Executive Officer (CEO), Asim Rauf, said a two-hour window for pharmaceutical companies was still available, during which a cell headed by a senior Drap official meets visitors. A report on their issues is compiled, and a timeline is given for resolving their issues, he added.

“In addition to that, we have introduced an online system to facilitate the industry. Both systems are working simultaneously. What is not being allowed is the free interaction of visitors with each and every officer in Drap, which is the practice everywhere in the world,” Asim Rauf added.

He maintained that as per the World Health Organisation (WHO) guidelines, they were trying to facilitate the pharmaceutical companies and ensure transparency, as they had noticed incidents where officials either caused unnecessary hurdles in regulatory issues or pharmaceutical industry representatives tried to influence the authority’s officials.

On the other hand, the pharmaceutical industry has strongly objected to Drap’s policy of barring the entry of their representatives into the authority’s offices, questioning how a regulator could prevent the industry’s representatives from interacting with its officials.

“Drap is not allowing pharmaceutical industry representatives to interact with its officers since its offices have been relocated to the NIH complex. Earlier, they provided a two-hour window for regulatory affairs officials from the pharmaceutical companies to interact with Drap officers, and now they are asking them not to visit the Drap offices at all, which is unjustified,” said Mian Khalid Misbah, Chairman of the Pakistan Pharmaceutical Manufacturers Association (PPMA).

He maintained that Drap’s policy to allow pharmaceutical companies’ representatives to meet a focal person within a two-hour window during office hours was not effective, and companies were complaining that their issues were not being resolved timely.

“As far as the online system is concerned, it is also not perfect. Often, we face hurdles while uploading documents and seeking guidance on many issues faced by the companies. Person-to-person interaction is the best solution to improve the functioning of the pharmaceutical industry and provide quality medicines and therapeutic goods to people on time,” the PPMA office-bearer said.

He maintained that he would raise the concerns of the companies with the Drap chief as both the online system and disallowing companies’ representatives to interact with its officials were not effective and causing inconvenience to the industry.